NCT03961204

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

Conditions

• Multiple Sclerosis (MS)

Interventions

Type	Name	Description
OTHER	Data Collection	No study treatment was administered as part of this study

Timeline

• Start date: 2019-08-15
• Primary completion: 2021-02-27
• Completion: 2021-05-13
• First posted: 2019-05-23
• Last updated: 2023-10-31
• Results posted: 2022-05-05

Locations

99 sites across 29 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Italy, Lebanon, Lithuania, Norway, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Switzerland, Tunisia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study